This prospective, placebo-controlled, randomized, monocentric, double-blind, crossover study in healthy volunteers aims to assess the effect of a single dose of 2 g G-PUR® on bioavailability of dietary fumonisin and to evaluate safety and tolerability.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
7
Oral administration (Intervention period I)
Oral administration (Intervention period II)
Intervention period I
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria
The bioavailability of fumonisin is estimated based on the concentration of urinary biomarkers FB1 and FB2
Time frame: 24 hours
Incidence of (serious) adverse device effects
Time frame: 19 days
Urinary biomarkers FB1 and FB2 (separately and sum of FB1 and FB2)
Time frame: 24 hours
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Intervention period II